title: Uninformed decisionmaking. The case of surrogate research consent.
abstract: A New York court recently struck down state Office of Mental Health regulations governing research involving subjects with impaired decisionmaking capacity. The court held that neither incapacitated adults nor minors could participate in any research protocol that contained a nontherapeutic element, irrespective of possible benefits to the subject or the importance of the knowledge to be gained. Although the decision rested on a technical point of law and dealt only with psychiatric research, the court's holding has significantly broader implications.
authors.affiliation: New York State Office of Mental Health, USA.
authors.forename: S
authors.initials: S
authors.lastname: Haimowitz
authors.forename: S J
authors.initials: SJ
authors.lastname: Delano
authors.forename: J M
authors.initials: JM
authors.lastname: Oldham
mesh_terms: D000293:Adolescent; D000328:Adult; D035843:Biomedical Research; D028744:Ethics Committees, Research; D035082:Federal Government; D033161:Government Regulation; D006805:Human Experimentation; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D033222:Judicial Role; D016743:Mental Competency / Q000331:legislation & jurisprudence*; D001523:Mental Disorders; D028642:Persons with Psychiatric Disorders; D033242:Minors; D009518:New York; D033281:Nontherapeutic Human Experimentation; D033282:Parental Consent; D018579:Patient Selection; D018570:Risk Assessment; D036302:Therapeutic Human Experimentation; D014481:United States